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New treatment option for Ovarian Cancer
Official title Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
ClinicalTrials.gov ID: NCT04520139
What this study is testing
What is N-Acetyl-Cysteine?
N-Acetyl-Cysteine is an investigational medicine, being studied as a potential treatment for ovarian cancer.
Also referred to as NAC Sustain, NAC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)
- Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Life expectancy \> 1 year
- Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
You likely can't join if
- Prior history of any cancer (other than non-melanoma skin cancer)
- Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
- Prior severe head injury
- Has a history of dementia or other neurodegenerative disorders
- Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
- Presence of known brain metastases
See the full eligibility criteria
- Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)
- Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Life expectancy \> 1 year
- Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
- Prescribed a minimum of six cycles of platinum-based chemotherapy
- Adequate organ function as defined below:
- Hemoglobin \> 9 g/dL
- Leukocytes \>1,500/mcl
- Absolute Neutrophil Count \> 1,000/mcL
- Platelets \> 125,00/mcL
- total bilirubin Within normal institutional limits
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal
- Serum creatinine \< 1.5 mg/dL.
- Prior history of any cancer (other than non-melanoma skin cancer)
- Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
- Prior severe head injury
- Has a history of dementia or other neurodegenerative disorders
- Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
- Presence of known brain metastases
- Has an active infection requiring treatment
- Known immunosuppressive disease
- Has active systemic autoimmune diseases such as lupus
- Receipt of systemic immunosuppressive therapy
- Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
- Pregnant of breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.